COVID-19 Antigen Rapid Test
Manufactured by Zhejiang Anji Saianfu Biotech Co. Ltd., China - www.reopentest.com
Device identification number
1198
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://www.reopentest.com/ifu
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
7200 AU/mL
Accuracy
91 %
Clinical Sensitivity
90 %
Clinical Specificity
98 %
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements